Cleared Traditional

K941706 - OPTI-PLAST ANGIOPLASTY CATHETER

K941706 is an FDA 510(k) clearance for OPTI-PLAST ANGIOPLASTY CATHETER, manufactured by Vas-Cath, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K941706 · Vas-Cath, Inc. · Cardiovascular device
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Oct 1994
Decision
195d
Days
Class 2
Risk

K941706 is an FDA 510(k) clearance for the OPTI-PLAST ANGIOPLASTY CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on October 18, 1994 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K941706

510(k) Number K941706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1994
Decision Date October 18, 1994
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 261
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K941706.
BARD PERIPHERAL BALLOON DILATATION CATHETER
K942400 · C.R. Bard, Inc. · Nov 1994
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · Cordis Corp. · Nov 1994
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1994
MS CLASSIQUE BALLOON CATHETER
K942293 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1994
MS CLASSIQUE BALLOON CATHETER
K943298 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1994
SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS
K942154 · Boston Scientific Scimed, Inc. · Aug 1994